QA Associate - (Night Shift),

QA Associate - (Night Shift),

Oxford Full-Time 30000 - 42000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Join us as a QA Associate, ensuring product quality and compliance in a fast-paced environment.
  • Company: Baxter is a global leader in healthcare, dedicated to saving and sustaining lives for over 85 years.
  • Benefits: Enjoy competitive pay, professional development, and a strong focus on work-life balance.
  • Why this job: Make a real impact on patient outcomes while working in a supportive and innovative culture.
  • Qualifications: Must have a degree in a science-related field and 2 years of GMP experience.
  • Other info: This role is night shift, working Sunday to Thursday from 6pm to 2am.

The predicted salary is between 30000 - 42000 £ per year.

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This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You\’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter\’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Summary
The Quality Assurance Associate will be responsible to support in the continuous compliance of Compounding Unit to cGMP and “Specials” manufacturing requirements, local procedural requirements and Baxter Corporate policies and assisting quality operation through the release of compounded product
They will ensure timely communication of significant GMP and product quality issues to QA Management, proactively identify and support implementation of continuous improvement opportunities in QA and Operations and investigate and report on Quality issues.
This role will work Sunday – Thursday between the hours of 10pm and 6am.
Essential Duties And Responsibilities

  • Assist in the release of manufactured products according to defined procedures
  • Perform ‘in-process’ checks, report and record any errors (e.g. CPI/NCR) according to defined procedures including:
    • Green Light to Release:
    • Facility status checks
    • Equipment and validated state checks
    • Physical product checks
    • Manufacturing and documentation checks
    • Check of any outstanding Quality issues with the batch or facility.
  • Supervisor checks throughout the compounding process (picking to release)
  • Escalate and resolve any observed product quality issues in a timely manner, ensuring GMP is adhered to at all times.
  • Ensure product complaints and service complaints are adequately investigated and appropriate corrective and/or preventative actions are implemented
  • Ensure that a schedule of environmental monitoring is in place that complies withGMP and that any out of limits or alerts are investigated and actions taken to correct and EM trend analysis

    • Ensure facility and process compliance through Real Time Risk Assessments and GEMBA walks, identifying actions and facilitating implementation.
    • Proactively identify and support implementation of continuous improvement opportunities in QA and Operations.
    • Comply with EHS/GMP/GDP/Company and Corporate policies and external regulatory requirements.
    • Review and approve planned and unplanned controlled system work orders (CSW) & Maximo.
    • Raise and Investigate non-conformance reports (NCRs), define, execute and track appropriate CA/PA actions
    • Support reviews of production processes (to meet regulatory and customer requirements) from a quality prespective
    • Support the qualification, maintenance and calibration activities from quality prespective as needed
    • Identify and escalated supplier issues supporting their investigation as per SCARs (Supplier Corrective Action Requests) or B2B (Baxter to Baxter complaints) process.

    Education And Qualifications
    Eligibility required: Resident and eligible to work in the UK or Ireland on a full-time basis.
    Education

    • English minimum equivalent to RQF Grade 2, EQF Grade 3 or SCQF Grade 5
    • Degree or BTEC (or equivalent) in Pharmaceutical or Science related subject

    Experience And Attributes
    Required;

    • 2 Years experience in a GMP Environment
    • Field of expertise preferred: Quality Assurance Production, Validation, Microbiology
    • Aseptic Manufacture of medicinal products is preferred but not required

    Preferred

    • Strong working knowledge of Microsoft Office programmes including Excel
    • Experience of TrackWise8 and TrackWise9

    What are some of the benefits of working at Baxter?

    • Competitive total compensation package
    • Professional development opportunities
    • High importance placed on work life balance
    • Commitment to growing and developing an inclusive and diverse workforce

    #IND-UKOPS
    #IND-UKCOM
    Equal Employment Opportunity
    Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
    Reasonable Accommodations
    Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
    Recruitment Fraud Notice
    Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

    Seniority level

    • Seniority level

      Entry level

    Employment type

    • Employment type

      Full-time

    Job function

    • Job function

      Quality Assurance

    • Industries

      Medical Equipment Manufacturing

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    QA Associate - (Night Shift), employer: Baxter International Inc.

    At Baxter, we are not just a company; we are a community dedicated to saving and sustaining lives. Our commitment to employee growth is reflected in our professional development opportunities and a strong emphasis on work-life balance, all within a culture that values inclusivity and diversity. Join us in a role where your contributions directly impact patient outcomes, and experience the fulfilment of working in a pioneering environment that has been transforming healthcare for over 85 years.
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    Contact Detail:

    Baxter International Inc. Recruiting Team

    StudySmarter Expert Advice 🤫

    We think this is how you could land QA Associate - (Night Shift),

    Tip Number 1

    Familiarise yourself with cGMP regulations and Baxter's specific policies. Understanding these guidelines will not only help you in the interview but also demonstrate your commitment to quality assurance.

    Tip Number 2

    Highlight any experience you have in a GMP environment, especially if it relates to quality assurance or product release. Be ready to discuss specific examples of how you've contributed to compliance and quality improvements.

    Tip Number 3

    Prepare to discuss your familiarity with tools like TrackWise8 and TrackWise9. If you have experience with these systems, be sure to mention it, as it can set you apart from other candidates.

    Tip Number 4

    Since this role involves night shifts, be prepared to talk about your flexibility and ability to work during these hours. Showing that you're comfortable with the schedule can make a positive impression.

    We think you need these skills to ace QA Associate - (Night Shift),

    Knowledge of cGMP regulations
    Quality Assurance principles
    Attention to Detail
    Problem-Solving Skills
    Experience in a GMP Environment
    Ability to perform in-process checks
    Strong communication skills
    Data Analysis and Reporting
    Environmental Monitoring Compliance
    Risk Assessment Techniques
    Continuous Improvement Methodologies
    Familiarity with TrackWise8 and TrackWise9
    Proficiency in Microsoft Office, especially Excel
    Understanding of Quality Control processes
    Ability to investigate and resolve product quality issues

    Some tips for your application 🫡

    Tailor Your CV: Make sure to customise your CV to highlight relevant experience in Quality Assurance and GMP environments. Emphasise any specific skills or knowledge related to pharmaceutical or science subjects that align with the job description.

    Craft a Strong Cover Letter: Write a compelling cover letter that explains why you are passionate about working at Baxter and how your background makes you a suitable candidate for the QA Associate role. Mention your understanding of their mission and how you can contribute to it.

    Highlight Relevant Experience: In your application, clearly outline your previous experience in quality assurance, particularly in GMP settings. Include specific examples of how you've contributed to compliance and continuous improvement in past roles.

    Proofread Your Application: Before submitting, thoroughly proofread your application materials. Check for spelling and grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is crucial in QA roles.

    How to prepare for a job interview at Baxter International Inc.

    Understand GMP Regulations

    Familiarise yourself with Good Manufacturing Practices (GMP) as they are crucial for the QA Associate role. Be prepared to discuss how you have adhered to these standards in your previous experience.

    Showcase Problem-Solving Skills

    Prepare examples of how you've identified and resolved quality issues in past roles. Highlight your proactive approach to continuous improvement, as this is a key responsibility in the position.

    Demonstrate Team Collaboration

    Baxter values teamwork, so be ready to share experiences where you've successfully collaborated with others. Emphasise your ability to communicate effectively, especially in high-pressure situations.

    Ask Insightful Questions

    Prepare thoughtful questions about Baxter's commitment to quality assurance and continuous improvement. This shows your genuine interest in the role and helps you assess if the company aligns with your values.

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